A common question many teams ask as they face the transition to digital study documents is, “What if I get audited?” Inspections evoke fear because negative audit findings significantly impact everyone. Areas of high risk include missing documents, accurate delegation of authority logs, reporting delays, and inadequate monitoring or PI oversight. Given these risks, some teams believe that the best plan is to do nothing and stick to routine. However, the traditional paper-based routine, though familiar and comfortable, increases all of these risks.

The best plan to ensure Audit Ready status is to make a strategic transition to digital today, before your next audit. Why?

  • Digital solutions reveal the unknown, making it easy to identify risks and proactively correct them.
  • Since most sponsors are requesting digital documents, digital solutions keep your site out of a treacherous half-paper, half-digital state where disorganization can occur.
  • Detailed 21 CFR Part 11 audit trails help you demonstrate to auditors and monitors the GCP steps you know your site is already taking.
  • Ensures compliance leveraging a single source of truth across all your studies.

The benefits of this transition far outweigh the risks – which is why centers and sponsors around the world are making the change each day. It is also why the FDA is partnering with stakeholders to help drive digital transitions. So, how do you make this strategic transition to digital so that you are audit ready?


1) Know what the FDA expects

In discussions with Florence, the FDA made three things clear:

  1. eRegulatory tools are acceptable. See FDA & ICH guidance documents here in another blog post.
  2. Your eRegulatory tool must be 21 CFR Part 11 compliant. Validated software with audit trails is key not only for eSignatures but for the pedigree of documents you’re storing.
  3. Your eRegulatory tool must make it easy for your team to guide the auditor through your study documents. The tool can’t encumber discovery.  

2) Develop and document your digital strategy

  • Partner with your digital vendor to write simple SOPs documenting your digital document guidelines.
  • Develop SOPs at the right scope. Document the core tasks in a process, but not the details. This creates a path that your team, and auditors, can follow, but doesn’t create overwhelming     detail that would make compliance impossible in practice.
  • Ensure all members of your team read the SOPs and are well trained on the digital tool you choose. Document their acknowledgement and training.
  • Review your SOPs at least annually to ensure they are up-to-date and your team is in compliance. Have your SOPs ready for review by team members, monitors, and inspectors.

3) Choose the right vendor

  • The vendor you choose should focus on creating and maintaining a tool that is easy for all team members to use. Simple is key.
  • The tool must be frequently validated and the vendor should provide proof, upon request, of validation.
  • The vendor should be willing to partner with your team administrators to set up appropriate digital security levels to enable privacy and data security.

4) Optimize workflows

  • As you begin working inside your chosen tool, the first step should be to set up workflow reminders such as document placeholders and due and expiration dates, as well as tasks, to alert team members of items that need attention.
  • File your eSignature non-repudiation statement with the FDA and then utilize eSignatures for documentation – specifically for time-sensitive documents.
  • Train your team on these workflows and ensure compliance.

5) Eliminate paper shadow charts

  • Maintaining consistent documentation in shadow charts is hard. Redundancy leads to risky errors when items need to be tracked, updated, and filed.
  • If possible, select an eBinder tool capable of connecting with EHR’s to receive source and other clinical documents such as labs. To maintain HIPAA compliance, the tool must have role based permissions and redaction capabilities to protect PHI.
  • Establish workflows for adverse event reviews utilizing digital shadow charts – which can be accessed from anywhere in the world.

6) Review your electronic binder integrity frequently

  • Choose a tool with a clear view that highlights high risk areas.
  • Review your audit trails to ensure team compliance and consistency.
  • Understand how to find items quickly and even download them to print if requested during an inspection.


At Florence we understand the risks and fears associated with inspections and changes in routine. In fact, our eBinder Suite™ was designed by security experts and research coordinators, who have successfully survived audits, to facilitate the transition to digital in an easy to use, secure HIPAA and 21 CFR Part 11 compliant environment. We are dedicated to helping teams move from audit risk to audit ready. Contact us at info@florencehc.com for information on how your team can make the transition today.